Coffee and Metabolic Health Outcomes (COMETH)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nestlé
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01738399
First received: November 28, 2012
Last updated: January 16, 2013
Last verified: March 2012
  Purpose

The purpose of the study is to investigate the long-term (24 weeks) effects of coffee consumption on insulin sensitivity in insulin resistant individuals.


Condition Intervention
Insulin Resistance
Dietary Supplement: Coffee
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Influence of Coffee Consumption on Insulin Sensitivity in Overweight and Insulin Resistant Subjects.

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Change in insulin sensitivity when compared to baseline as measured using the euglycemic hyperinsulinemic clamp. [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fasting plasma glucose concentration from baseline to 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma glucose concentration from baseline to 24 weeks [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma total adiponectin concentrations from baseline to 12 weeks [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change in fasting plasma total adiponectin concentrations from baseline to 24 weeks [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coffee
Subjects take 4 cups of coffee mix per day for 24 weeks
Dietary Supplement: Coffee
Placebo Comparator: Placebo
Subjects take 4 cups of placebo per day for 24 weeks
Dietary Supplement: Placebo

Detailed Description:

Coffee is a major source of the phenolic acid chlorogenic acid and a substantial source of trigonelline, niacin, lignans magnesium, and potassium. Several of these compounds have been shown to improve glucose metabolism in animal models. Consumption of coffee was inversely associated with the risk of type-2 diabetes in prospective cohort studies across the world. Consumption of 3 to 4 cups of coffee per day was associated with an approximately 25% lower risk of type-2 diabetes. However, direct evidence of the efficacy of coffee to reduce blood glucose and insulin resistance parameters in humans from randomized trials is still lacking. In recent small trials of short duration (up to 6 weeks) coffee consumption increased levels of the insulin-sensitizing hormone adiponectin, but did not significantly improve insulin sensitivity These results suggest that a larger longer-term trial of the effects of coffee consumption on directly measured insulin sensitivity is warranted.

  Eligibility

Ages Eligible for Study:   35 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects classified as being insulin-resistant in the screening visit. Subjects should have a non-diabetic fasting plasma glucose concentration (< 7.0 mM) and a HOMA-IR > 2.2. The HOMA-IR was demonstrated as a reliable indicator of insulin resistance strongly correlated with values obtained by clamp (4). The cut-off value of the HOMA-IR was defined according to data obtained in the Singapore cohort. It corresponds to the 75th percentile of the population.
  • Age: ≥ 35 to ≤ 69 years old
  • Body mass index : ≥ 22.5 to ≤ 35.4 kg/m2
  • Users of at least 1 cups of caffeinated coffee per day who are willing to be randomized to any of the interventions.
  • Subjects should be willing to stop consuming caffeinated soft drinks or supplements during the study and to drink coffee with non-dairy creamer.
  • Non-smokers (< 1 cigarette per week)
  • Participants have been weight stable for at least -8 weeks pre-ceding the screening visit (± 2.5 kgs).
  • Chinese, Malay and Indian ethnicity

Exclusion Criteria:

Subjects representing one or more of the following criteria are excluded from participation in the study:

  • Any condition/illness that may affect the study outcomes or would make participation potentially harmful such as pregnancy or breastfeeding, diabetes mellitus, heart disease, stroke, hypertension, malabsorption syndromes, GERD, a history of ulcer, clotting or bleeding disorders,allergy to the test beverage, allergy to insulin, according to a detailed medical history.
  • Participants who are allergic to foods may be excluded based on the investigator's discretion.
  • Participants consume > 2 alcoholic servings/day on a regular basis and > 8 caffeinated servings (based on tea and coffee)/day
  • Present drug abuse or use of medications that could interfere with the treatment including bronchodilators, quinolone antibiotics, monoamine oxidase inhibitors, anxiolytics, ranitidine, corticosteroids, growth hormone, anti-hypertensives. These conditions will be screened based on subject reporting. Participants will be asked to bring in their current medications at the time of screening, and these will be checked by the study-staff.
  • Subject is taking traditional medications, herbal or dietary supplements that may affect the study outcome in the opinion of the investigators.
  • Subject who cannot be expected to comply with the study procedures in the opinion of the investigators.
  • Currently participating or having participated in another clinical trial during the last 12 weeks prior to the beginning of this study.
  • Premenopausal women with self-reported irregular menstrual cycles or peri-menopausal women (participants who stopped getting their menses for less than 48 weeks ).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738399

Contacts
Contact: Rob M van Dam, PhD +65 65164980 ephrmvd@nus.edu.sg
Contact: Salome A Rebello, PhD +65 65168557 lsisar@nus.edu.sg

Locations
Singapore
Saw Swee Hock School of Public Health Recruiting
Singapore, Singapore, 117597
Contact: Rob M van Dam    +65 65164980    ephrmvd@nus.edu.sg   
Contact: Salome Rebello    +65 65168557    lsisar@nus.edu.sg   
Principal Investigator: Rob M van Dam         
Sub-Investigator: Kee Seng Chia         
Sub-Investigator: Salome Rebello         
Sub-Investigator: Khoo Eric         
Saw Swee Hock School of Public Health Recruiting
Singapore, Singapore, 117597
Contact: Rob M van Dam    +65 65164980    ephrmvd@nus.edu.sg   
Contact: Salome Rebello    +65 65168557    salome_antonette_rebello@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Nestlé
Investigators
Principal Investigator: Rob M van Dam Saw Swee Hock School of Public Health, National University of Singapore
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01738399     History of Changes
Other Study ID Numbers: 11.09.NRC
Study First Received: November 28, 2012
Last Updated: January 16, 2013
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Insulin resistance
Coffee
Glucose metabolism

Additional relevant MeSH terms:
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014